FDA Law

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

GeriPal

MAY 5, 2022

Including more hospital utilization or healthcare utilization, maybe cognitive impairment issues. And there’s multiple survival analyses looking at incident dementia, and hearing loss is strong, independently associated with the time to event dementia. My own work focuses on hospitalization and health utilization over time.

IT 102

IT Screening Hospital Clinic 102

GeriPal

DECEMBER 7, 2023

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. As we age, our body’s capacity to adapt to things becomes a little more challenge. They can save a lot of money.

Healthcare 128

Healthcare IT Education Community 128

FDA Law

NOVEMBER 8, 2022

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). If you have a good relationship with the review team, Dr. Maisel encourages a brief phone call or quick email to obtain informal feedback. Dr. Maisel also discussed disposition of already distributed devices.

Manufacturing 59

Manufacturing Medical Patient-Centered Provider 59